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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Heart and Stroke Foundation of Ontario | OTHER |
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Rationale: Patients with severe ventricular dysfunction and coronary disease have high morbidity and mortality. They may benefit from revascularization, but have significant peri-operative morbidity and mortality. Positron emission tomography (PET) imaging with F-18-fluorodeoxyglucose (FDG) can detect viable myocardium that may recover from revascularization in such patients. It is unclear whether use of FDG PET in this population is improves outcome or is cost-effective.
Objectives: The principal aim is to determine whether FDG PET-guided therapy is effective versus standard care. Secondary objectives are to determine whether FDG PET-guided therapy improves LV function, quality of life and is good value for money versus standard care.
Patients with severe ventricular dysfunction and coronary artery disease have high morbidity and mortality but may benefit from revascularization. However, there is also significant peri-operative morbidity and mortality among these patients. This accounts for the variable approach to these patients in different cardiac centres. Clearly this patient group has the most to gain when coronary revascularization is beneficial, but also the most to lose when it is not helpful. There is a need for an approach that can better define patients with severe ventricular dysfunction due to ischemia, who will be more likely to benefit from revascularization. Positron emission tomography (PET) imaging with F-18-Fluorodeoxyglucose (FDG) has been used to evaluate patients with ventricular dysfunction, to detect ischemic but viable myocardium more likely to recover from revascularization. Recently retrospective studies have shown that FDG PET can identify patients at high risk for cardiac events if they do not undergo revascularization. However, these studies did not evaluate whether FDG PET actually directed therapy decisions and because of their study design, could not determine whether FDG PET altered patient outcome. Our recent studies have shown that FDG PET can have important impact on therapy decisions and that patients with ischemic but viable myocardium are at increased risk. However it remains unclear whether an approach which utilizes FDG PET to define ischemic but viable myocardium can have a beneficial effect on patient outcome. It is also important to consider the potential clinical impact of FDG PET balanced against its limited availability. In addition, despite the cost of the technology, preliminary data from our group and others suggest a potential cost savings. Accordingly, a prospective randomized study is needed to evaluate whether FDG PET directed therapy has a beneficial effect on patient outcome and is cost-effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET guided Therapy | Active Comparator | Patients will be randomized to undergo positron emission tomography aspart of their clinical work up |
|
| Standard care | Active Comparator | Patients will be randomized to standard care will under go other types of imaging or work up for revascularization without PET imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positron emission tomography: FDG viability imaging | Procedure | FDG PET viability imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to occurence of the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of the composite endpoint; individual components of the composite endpoint; quality of life, costs, and cost-effectiveness of PET-guided therapy versus control. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rob SB Beanlands, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17996568 | Background | Beanlands RS, Nichol G, Huszti E, Humen D, Racine N, Freeman M, Gulenchyn KY, Garrard L, deKemp R, Guo A, Ruddy TD, Benard F, Lamy A, Iwanochko RM; PARR-2 Investigators. F-18-fluorodeoxyglucose positron emission tomography imaging-assisted management of patients with severe left ventricular dysfunction and suspected coronary disease: a randomized, controlled trial (PARR-2). J Am Coll Cardiol. 2007 Nov 13;50(20):2002-12. doi: 10.1016/j.jacc.2007.09.006. Epub 2007 Oct 10. | |
| 19761983 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| PET imaging | Other | PET viability imaging |
|
| Background |
| D'Egidio G, Nichol G, Williams KA, Guo A, Garrard L, deKemp R, Ruddy TD, DaSilva J, Humen D, Gulenchyn KY, Freeman M, Racine N, Benard F, Hendry P, Beanlands RS; PARR-2 Investigators. Increasing benefit from revascularization is associated with increasing amounts of myocardial hibernation: a substudy of the PARR-2 trial. JACC Cardiovasc Imaging. 2009 Sep;2(9):1060-8. doi: 10.1016/j.jcmg.2009.02.017. |
| 20237039 | Background | Abraham A, Nichol G, Williams KA, Guo A, deKemp RA, Garrard L, Davies RA, Duchesne L, Haddad H, Chow B, DaSilva J, Beanlands RS; PARR 2 Investigators. 18F-FDG PET imaging of myocardial viability in an experienced center with access to 18F-FDG and integration with clinical management teams: the Ottawa-FIVE substudy of the PARR 2 trial. J Nucl Med. 2010 Apr;51(4):567-74. doi: 10.2967/jnumed.109.065938. Epub 2010 Mar 17. |
| 22138342 | Background | Shukla T, Nichol G, Wells G, deKemp RA, Davies RA, Haddad H, Duchesne L, Freeman M, Gulenchyn K, Racine N, Humen D, Benard F, Ruddy TD, Chow BJ, DaSilva J, Garrard L, Guo A, Chen L, Beanlands RS. Does FDG PET-assisted management of patients with left ventricular dysfunction improve quality of life? A substudy of the PARR-2 trial. Can J Cardiol. 2012 Jan-Feb;28(1):54-61. doi: 10.1016/j.cjca.2011.09.012. Epub 2011 Dec 3. |
| 27609816 | Derived | Mc Ardle B, Shukla T, Nichol G, deKemp RA, Bernick J, Guo A, Lim SP, Davies RA, Haddad H, Duchesne L, Hendry P, Masters R, Ross H, Freeman M, Gulenchyn K, Racine N, Humen D, Benard F, Ruddy TD, Chow BJ, Mielniczuk L, DaSilva JN, Garrard L, Wells GA, Beanlands RS; PARR-2 Investigators. Long-Term Follow-Up of Outcomes With F-18-Fluorodeoxyglucose Positron Emission Tomography Imaging-Assisted Management of Patients With Severe Left Ventricular Dysfunction Secondary to Coronary Disease. Circ Cardiovasc Imaging. 2016 Sep;9(9):e004331. doi: 10.1161/CIRCIMAGING.115.004331. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D018754 | Ventricular Dysfunction |